Sagent Pharmaceuticals Inc recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceutic…

Recall date

April 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1274-2019

FDA classification

Class II

Brand / firm

Sagent Pharmaceuticals Inc

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02